Clinical experience with transcutaneous supraorbital nerve stimulation in patients with refractory migraine or with migraine and intolerance to topiramate: a prospective exploratory clinical study

DOI: https://doi.org/10.1186/s12883-017-0869-3

Abstract-Summary Non-invasive neurostimulation, including the Cefaly® device, for the treatment of various types of pain is a relatively new field of interest.

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The aim of the present study was to explore the clinical experience with Cefaly® in a cohort of migraine patients previously refractory or intolerant to topiramate prophylaxis.

A prospective, multi-center clinical study was performed in patients diagnosed with episodic or chronic migraine with a previous failure to topiramate treatment requiring prevention with Cefaly® according to the treating physician’s suggestion. A 1-month period of baseline observation was followed by a 3-month period of observation during the use of transcutaneous supraorbital nerve stimulation (t-SNS) with Cefaly® as the only preventive treatment.

Twenty-three patients (65.7%) expressed their satisfaction and intent to continue

treatment with Cefaly®.

Three-months of preventive treatment for episodic or chronic migraine with t-SNS proved to be an effective, safe and well tolerated option for the treatment of patients with migraine who were intolerant or did not respond to topiramate.

Extended: The aim of the present study was to explore and share the clinical experience with Cefaly® in a cohort of migraine patients previously refractory or intolerant to preventive treatment with topiramate, as this is a common situation in clinical practice.

Background Medications are the mainstream of migraine management; however, preventive treatment is often far from optimal [111].

Preventive treatment for migraine is usually considered when migraine pain is

present more frequently than twice a week [507, 508].

Topiramate is currently the most commonly used first-line approved preventive

medication for migraine [509].

Adherence to migraine preventive medications, including topiramate, may be

insufficient.

Among preventive medication choices, patients are reported to adhere best, but not optimally to topiramate, with adverse events being the most common reason for topiramate discontinuation [20].

The aim of the present study was to explore and share the clinical experience with Cefaly® in a cohort of migraine patients previously refractory or intolerant to preven- tive treatment with topiramate, as this is a common situation in clinical practice.

Methods This study was done to explore the efficiency and safety of Cefaly® in migraine pre- vention in a population of patients previously refractory or intolerant to topiramate. Patients were diagnosed with episodic or chronic migraine, needed preventive treatment according to the treating physician’s opinion, and they had not responded to previous topiramate treatment, either due to inefficacy or due to intolerability or safety issues.

Changes in total headache days, number of HA days with intensity ≥5/10 and days with acute medication use were analysed from baseline to the last observation or Month-3 of active treatment.

In order to evaluate longitudinal changes over time for the number of headache days, the number of medication doses or the number of adverse events (AEs), Linear

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Mixed Models were performed, with patients modelled as a random effect, time (study month), group (e.g. whether they were satisfied or not), and their interaction modelled as fixed effects.

Results We recorded significant changes in headache days, headache days with pain inten- sity ≥5/10 and use of analgesics in patients under treatment with Cefaly® from 4 weeks baseline to the 4 weeks prior to last observation or at Month-3 (by a median of 2 days, p < 0.001; 2 days, p < 0.001; 4 doses, p < 0.001, respectively).

Twenty three patients out of 35 (65.7%) expressed their satisfaction and intent to

continue treatment with Cefaly®.

The number of participants with a 50% or greater reduction in frequency of head- aches at the end of the study vs. the baseline (responder rate) was 1/35, 0/32 and 1/31, for the 1st, 2nd and 3rd month of active treatment, respectively.

The patients with chronic migraine (6 in our cohort) had similar percentages of satisfaction/intent to continue treatment compared to the patients with episodic migraine (66.7% vs. 65.5% respectively).

Twelve out of 35 (34.3%) patients reported an AE.

Discussion We explored the efficiency and safety of Cefaly® used in episodic and chronic migraine prevention, after a failed trial of topiramate.

A comparable percentage (70.59%) of satisfied patients was found in the verum group of the prospective, multicentre, double- blinded, randomized and sham-con- trolled PREvention of MIgraine using CEfaly® (PREMICE) study, which enrolled migraine patients with at least 2 attacks per month [510].

It also emphasizes the importance of a full 3-month trial of t-SNS before deter- mining efficacy, as it has been suggested by the researchers of the PREMICE study, that the maximum reduction in migraine frequency occurred only after 3 months of treatment with Cefaly® [510].

We specifically aimed to determine whether the primary reason for the failure of topiramate—lack of efficacy or AEs—might be related to the possible future response to Cefaly®.

Conclusions Three months of preventive treatment for episodic and chronic migraine with t-SNS (Cefaly®) proved to be an effective, safe and well tolerated treatment option in patients having failed to respond to topiramate due to either lack of efficacy or toler- ability/safety issues.

Further studies are needed, leading eventually to a definitive phase-3 clinical trial, with a long-term follow-up of at least 1 year, as well as an economic evalua- tion, before treatment with Cefaly® is widely adopted.

Acknowledgement A machine generated summary based on the work of Vikelis, Michail; Dermitzakis, Emmanouil V.; Spingos, Konstantinos C.; Vasiliadis, Georgios G.; Vlachos, George S.; Kararizou, Evaggelia. 2017 in BMC Neurology.

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